Shiley Neonatal/Pediatric Tracheostomy Tube— 510(k) K182861

Substantially Equivalent

Covidien

FDA 510(k) clearance K182861 for Shiley Neonatal/Pediatric Tracheostomy Tube, Substantially Equivalent on 2019-03-22. Applicant: Covidien.

Clearance details

Applicant: Covidien
Product code: Code JOH
Advisory panel: Anesthesiology
Date received: 2018-10-11
Decision date: 2019-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JOH

product code JOH

Death: 42
Injury: 1,344
Malfunction: 5,608
Other: 1
Total: 6,995

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.